Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
other: Any kind of reliability rating is not considered to be applicable, since human studies/reports are not conducted/reported according to standardised guidelines
Rationale for reliability incl. deficiencies:
other: Review article about disodium disulfite covering different endpoints including sensitisation. This endpoint study record summarises the information about sensitisation.

Data source

Reference
Reference Type:
review article or handbook
Title:
Disodium disulphite
Author:
Anonymous
Year:
2001
Bibliographic source:
OECD SIDS

Materials and methods

Type of sensitisation studied:
respiratory
skin

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): disodium disulfite

Method

Type of population:
general
occupational
Details on study design:
no data

Results and discussion

Results of examinations:
In a few cases allergic contact dermatitis as well as positive patch-testing was observed (Jacobs, 1992; Apetato, 1986; Sokol, 1990; Petersen, 1990; Larame, 1989; Vestergaard and Andesen, 1995)*. Given the wide-spread use, the number of cases is considered to be low.
Disodium disulfite is not irritating to the skin but irritating to the eyes. It is not considered as skin sensitizer and also unlikely to induce respiratory sensitization but may enhance symptoms of asthma in sensitive individuals.

*References:
- Jacobs M C, R.J.G. Rycroft. Contact dermatitis and asthma from sodium metabisulfite in a photographic technician. Contact Dermatitis. 33, 65-66, 1995.
- Apetato M, M.S.J. Marques. Contact dermatitis caused by sodium metabisulfite. Contact Dermatitis. 14, 194, 1986.
- Sokol W.N, I.B. Hydick. Nasal congestion, urticaria, and angioedema, caused by IgE-mediated reaction to sodium metabisulfite. J. Allerg Clin Immunol. 65, 233-238, 1990.
- Petersen P.E, R.B.Evans, M.A.Johnstone, W.R Handerson. Evaluation of ocular hypersensitivity to dipivalyl epinephrine by component eye-drop testing. J Allergy Clin Immunol. 85, 954-958, 1990.
- Larame B, P.M. Bedard, J. Hebert. Contact dermatitis to sulfating agents. J Allergy Clin Immunol. 28, 197, 1989.
- Vestergaard LL., K. E Andersen. Am. J. Contact Dermatitis. 6, 174-175, 1995

Applicant's summary and conclusion

Conclusions:
The following conclusion was given in the review: in a few cases allergic contact dermatitis as well as positive patch-testing was observed. Given the wide-spread use, the number of cases is considered to be low.
Disodium disulfite is not irritating to the skin but irritating to the eyes. It is not considered as skin sensitizer and also unlikely to induce respiratory sensitization but may enhance symptoms of asthma in sensitive individuals.